Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Summarized Purpose: Operates an archive and document control systems. Logs, stores, retrieves, and monitors circulation of records which may include analytical methods and protocols and project and general laboratory raw data or Investigator site files. Ensures compliance with applicable facility SOP's and FDA Good Pharmaceutical Practices (i.e. Good Laboratory Practices, Good Manufacturing Practices etc) including maintaining security of the archives. Essential Functions and Other Job Information: Essential Functions • Places data and other records in the facility archives and catalogs these items appropriately to facilitate prompt retrieval. Maintains appropriate tracking records in the archive database. • Prepares project and equipment notebooks in accordance with laboratory specifications. Assigns and distributes notebooks to laboratory staff. • Catalogues and maintains analytical method and protocol files. Provides controlled copies of analytical methods to laboratory staff, and maintains distribution records in the archive database. • Conducts reviews of study files prior to submission to permanent storage. • Interacts with commercial (offsite) archive facilities for data storage and retrieval. • Troubleshoots and resolves missing or incomplete documentation of the study boxes. • May provide training on departmental tasks as appropriate. Job Complexity Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice. Job Knowledge Applies acquired job skills and company policies and procedures to complete assigned tasks. Supervision Received Normally follows established procedures on routine work, requires instructions only on new assignments. Business Relationships Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation.